BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2543131 · Received April 20, 2012

    Report

    Report Number
    2531779-2012-03390
    Event Type
    Death
    Date Received
    April 20, 2012
    Date of Event
    September 10, 2010
    Report Date
    March 23, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN AUTOPSY REPORT WAS RECEIVED FROM THE CORONER WHICH CONFIRMED THAT THE IMMEDIATE CAUSE OF DEATH WAS CORONARY ATHEROSCLEROTIC DISEASE. OTHER SIGNIFICANT CONDITIONS WERE LISTED AS DIABETES KETOACIDOSIS AND BLUNT FORCE TRAUMA OF THE TRUNK AND EXTREMITIES. THE REPORT LISTED PERSONAL EFFECTS BUT DID NOT MENTION THE INSULIN PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2010. THE REPORTER STATED THAT THE PATIENT WAS FOUND AT HER HOME UNCONSCIOUS BUT WAS UNCERTAIN IF THE PATIENT WAS WEARING THE PUMP AT TIME OF DEATH. THE REPORTER NOTED THAT THE DEATH CERTIFICATE LISTED HEART ISSUES AND DIABETES AS THE CAUSES OF DEATH. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE HEALTH CARE PROVIDERS AND THE REPORTER WAS UNCERTAIN WHO PERFORMED THE AUTOPSY OR WHO WAS CARING FOR THE PATIENT AT TIME OF DEATH. THE REPORTER SAID THAT SHE WAS NOT AWARE OF SPECIFIC PUMP MALFUNCTION; SHE STATED THAT THE PATIENT ALLEGED THAT SHE HAD MANY ISSUES WITH THE PUMP AND WITH BLOOD GLUCOSE (BG) READINGS. THE REPORTER MENTIONED THAT, IN THE YEAR PRIOR TO DEATH, THE PATIENT PASSED OUT TWICE AND WAS HOSPITALIZED DUE TO AN UNSPECIFIED BG ISSUE. NO ADDITIONAL DETAILS OF THESE EVENTS ARE AVAILABLE. THE REPORTER SAID THAT THE PUMP WAS DISPOSED OF SHORTLY AFTER THE PATIENT'S DEATH. THE SHERIFF'S OFFICE / CORONER'S DIVISION WAS CONTACTED AND THE DEPUTY IN CHARGE OF THE CASE LOCATED THE PATIENT'S AUTOPSY REPORT. SHE REPORTED THAT THE AUTOPSY LISTED CORONARY ARTERY DISEASE AS THE PRIMARY CAUSE OF DEATH; THE REPORT LISTED THE DEATH AS UNDETERMINED AND ACCIDENTAL. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. ACCORDING TO THE PATIENT'S FILE, THERE WERE TWO COMPLAINTS AGAINST PUMPS RECEIVED BY THE PATIENT IN 2006 AND 2010: ON (B)(6) 2006 THE PATIENT SAID THAT THE PUMP WOULD NOT POWER ON AND ON (B)(6) 2010 THE PATIENT REPORTED THAT THE BATTERY LIFE WAS SHORTER THAN EXPECTED PER IFU. IN BOTH CASES, THE PUMP WAS REPLACED UNDER WARRANTY. THE PUMP ON HAND AT THE TIME OF THE PATIENT'S DEATH WAS SHIPPED TO THE PATIENT ON (B)(6) 2010 AND THERE ARE NO COMPLAINTS ON RECORD AGAINST THIS PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USE OF AN INSULIN PUMP, MALFUNCTION OR MISUSE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR